Debating the Benefits and Costs Of Major Surgery for Emphysema

By WARREN E. LEARY

Published: May 14, 1996

WASHINGTON, May 13—
An increasingly popular new surgery for emphysema that at first appears to defy logic is at the center of an intense debate among chest surgeons and health care providers concerning its effectiveness and cost.

The operation, called lung volume reduction surgery, is increasingly being offered at hospitals around the country, even as doctors argue about how it should be performed, which patients are likely to benefit and if its benefits are worth the risks and cost.

Experts agree that the operation is not a cure for emphysema, a common, degenerative lung disease that most often results from cigarette smoking. But while many say it offers hope for at least temporarily relieving the shortness of breath and dependence upon external oxygen of many seriously ill patients who are virtually bedridden, the question of long-term benefit and relief remains unanswered.

"The procedure has shown substantial benefit to some patients, but clearly there are some others who have not benefited and may have been made worse off," said Dr. Leonard D. Hudson, a professor of pulmonary and critical care medicine at the University of Washington in Seattle. He added that more data were needed.

Treating emphysema with lung reduction surgery involves removing 20 percent to 30 percent of the damaged lung tissue. The operation has touched off so much debate that the American Thoracic Society, which represents chest and lung specialists, issued a position paper today in New Orleans at its annual conference acknowledging the operation's promise, based upon preliminary studies, but urging caution in its use.

"At this point in time, the operation should not be considered experimental, although insufficient data are available to determine if lung volume reduction surgery should be considered standard therapy," said the society, the medical branch of the American Lung Association. "Since there are many questions to be answered," the statement continued, "we recommend that this operation be performed only at centers where these procedures can be more completely studied through clinical trials and extensive physiologic evaluations."

Dr. Hudson, who is president of the thoracic society, said in an interview that there was concern that the surgery was becoming too widespread too soon. "We are calling for caution," he said. "Until we know more about the surgery and what it takes for it to be successful, we think it is too early to have the procedure done at every hospital."

Concern about the cost of the procedure prompted the Health Care Financing Administration, the Federal agency that regulates Medicare, to stop paying for the surgery in January, citing questions about its safety and effectiveness. But some private insurers continue to cover the surgery. Studies show the costs of the operation, not including doctors' fees, range from $35,000 to more than $70,000, depending on complications and the amount of rehabilitation required.

A subsequent assessment by the Agency for Health Care Policy and Research of more than 3,000 procedures from 27 medical centers found current data inconclusive regarding the risks and benefits of the surgery. The study, requested by the financing administration, recommended limited Medicare reimbursement only for patients who were part of a national controlled trial of the procedure.

On April 24, the National Heart, Lung and Blood Institute announced that it would sponsor such a trial. The institute said it would support a seven-year randomized study of more than 2,500 patients at 10 to 15 centers to determine which of several types of lung reduction surgery worked best and which patients were most likely to benefit. The study will also examine how much of the reported benefit is due to the procedure and how much is a result of the aggressive medical therapy and rehabilitation required at centers that get the best results.

Dr. Gail G. Weinmann of the institute said: "There is a possibility that the incremental improvement of surgery is so small that it could be negligible after a year or two. But the only way to determine that is with a trial."

Emphysema, which afflicts an estimated two million Americans in varying degrees, results in irreversible tissue damage when the walls between the air sacs within the lung lose their ability to stretch and spring back. The disease, which generally spreads through both lungs, is characterized by enlargement of the air spaces and loss of the organ's elasticity, causing air to be trapped and impairing the exchange of oxygen and carbon dioxide.

Until recently, little could be done for patients with severe emphysema, many of whom cannot walk more than a few feet or do simple tasks without exertion and the need for supplemental oxygen to assist their inefficient, often overly distended lungs. Lung transplantation has become an option for some cases, with the number of transplants for emphysema patients increasing to 688 in 1994 from 2 in 1985, said the American Lung Association. But a shortage of transplant organs and rigorous criteria for the surgery prevent it from being the primary therapy for most patients.